EFFECTIVE DATE: July 20, 2020
ISSUE #: 3
PRESIDENT: Dr. Antonio Tillis (Interim)
The Committee for the Protection of Human Subjects (CPHS) is charged with
reviewing and approving all research projects affiliated with or conducted at the
University of Houston-Downtown (UHD) involving human subjects. Members of
the committee review projects with the goal of ensuring that research is conducted
in a manner that is morally and ethically sound to ensure the safety, health, and
welfare of research subjects, in a context of compliance with all relevant federal and
state laws and regulations.
1.2 Regulatory Requirements
In order to meet the requirements of human subject research review as required by
Title 45 Code of Federal Regulations (CFR), UHD vests this responsibility of
human subjects research in the Committee for the Protection of Human Subjects
(CPHS) and adopts the rules of the CFR in the establishment of its policies and
procedures. Changes to Title 45 Code of Federal Regulations Part 46, Protection of Human Subjects (45 CFR Part 46) shall constitute a revision to this policy statement
as well as to any operating procedures guiding the activities of the CPHS. [Any
reference to subsections (§) in this policy refers to the subsections of 45 CFR Part
46 unless otherwise noted.]
2.1 The definitions for this policy are those specifically adopted in the “Definitions for
purposes of this policy” section of the 45 CFR 46 (46.102), and in the definitions
sections of any other relevant federal and state law or regulation.
2.2 Cooperative research projects are those research projects that involve more than one
3.1 Federal Requirements
According to Title 45 Code of Federal Regulations Part 46, Protection of Human Subjects, the CPHS shall maintain and publish specific policies and procedures that will
be followed in the review of research involving human subjects. The policies and
procedures of the committee shall be maintained in the committee's Operating Policies
and Procedures for the Committee for the Protection of Human Subjects. The CPHS
makes these available on its website. The website also provides instruction for faculty
who seek approval for research that involves human subjects
3.2 Adjustments to Policies and Procedures
Changes to the committee's policies and procedures must be approved by the majority
of the members of the committee while meeting in a quorum.
Any research, scholarly, creative or educational study that involves human subjects in
which the data will not be exclusively used or reported for internal purposes only, falls
under the jurisdiction of the CPHS. Studies involving human subjects in which the
data will be presented externally to UHD, whether by presentation or publication,
must obtain CPHS approval prior to initiation of the study and collection of data.
Research on human subjects collected for internal purposes may not ever be used for
an external purpose unless CPHS approval and informed consent was obtained prior to
the collection of data.
If it is unclear whether the proposed research involves human subjects or is subject to
review by the CPHS, investigators should seek guidance from the chair of the
The committee shall review all subsequent changes in the approved protocol to ensure
compliance with state and federal regulations. Any substantial changes in the protocol,
emergence of problems, or development of hazardous conditions involving human
subjects must be reported immediately to the CPHS committee chairperson by the
Investigators do not abdicate ethical and legal responsibility merely by complying with
this policy. It is the responsibility of the principal investigator to obtain clearance from
the CPHS prior to the initiation of any research activity involving the use of human
subjects. Failure to do so may result in charges of research misconduct (as per PS
06.A.07- Misconduct in Research, Scholarly, Creative, and Government Sponsored
Activities Policy), institutional restrictions on research activities, as well as potentially
endangering all future federal funding to the University.
3.4 Committee Membership
Committee members shall be appointed for three-year terms, starting at the beginning
of the academic year, by the Provost. One third of the committee membership shall be
appointed each year, so that the committee always has approximately two-thirds of its
members with at least one year's service on the committee.
The research enterprise at UHD is not confined to the 9-month, Academic year. CPHS
committee responsibilities span the 12-month calendar year. All CPHS committee
members are expected to conduct all CPHS activities, including CPHS application
reviews, throughout the 12-month calendar year for the duration of their three-year
The committee's faculty membership shall be tenured or tenure-track faculty. Faculty
membership on the CPHS shall include two representatives from each academic
Non-faculty membership on the committee shall include at least one non-scientific
university staff member and one community representative not associated with the
Two additional positions on the committee shall include the Director of Sponsored
Programs and a representative of the Provost's Office. The representative of the
Provost's Office shall serve in an ex-officio capacity and have no voting rights.
The CPHS, in conjunction with the Faculty Senate for faculty appointments and Staff
Council for the non-scientific staff appointment, shall advise the Provost at the end of
each spring semester of its membership needs and its recommendations as to
appointments for the coming academic year. The committee shall also make
recommendations to the Provost, in conjunction with the Faculty Senate and Staff
Council, on replacement of members who have resigned from the committee. The chair
and the chair-elect are elected at the beginning of the academic year if the need exists.
The chair must have served at least one year on the CPHS.
The committee may, at its discretion, invite individuals with expertise and competence
in special areas to assist in the review of complex research issues.
3.6 Cooperative Research
In the conduct of cooperative research projects, each institution is responsible for
safeguarding the rights and welfare of human subjects and for complying with this
policy. With approval of the CPHS, an institution participating in a cooperative
research project may enter into a joint review arrangement, rely upon the formal
review of another qualified human subjects committee, or make similar arrangements
for avoiding duplication of effort.
Research projects in which the primary investigator is not a current UHD faculty or
staff member must obtain a UHD faculty sponsor to serve as a Co-investigator and
sponsor for research projects involving human subjects at UHD.
The University of Houston-Downtown's Committee for the Protection of Human
Subjects shall prepare and maintain adequate documentation of the committee's
activities, including the following:
3.7.1 Copies of all research proposals reviewed, scientific evaluations, if any, that
accompany the proposals, approved sample consent documents, progress
reports submitted by investigators, and reports of injuries to subjects.
3.7.2 Minutes of the committee meetings which shall be in sufficient detail to show
attendance at the meetings; actions taken by the committee; the vote on these
actions including the number of members voting for, against, and abstaining;
the basis for requiring changes in or disapproving research; and a written
summary of the discussion of controversial issues and their resolution.
3.7.3 Records of continuing reviewing activities.
3.7.4 Copies of all correspondence between the committee chair acting on behalf of
the CPHS and investigators.
3.7.5 A list of committee members and their dates of service to the CPHS.
3.7.6 Written policies and procedures of the committee outlining the review system
(Committee for the Protection of Human Subjects Operating Procedures).
3.7.7 Statements of significant new findings provided to subjects. The Committee
shall ensure that records are retained in a manner consistent with UH- System,
state, and federal regulations.
3.8 University Review
Research covered by this policy that has been approved by the CPHS may be subject
to further appropriate review and approval or disapproval by officials at the university
(for example, review by the Office of Sponsored Programs). However, officials of the
university may not approve research that has been disapproved by the CPHS. (§
There are no additional procedures for this policy.
Responsible Party (Reviewer): President
Review: Every three years on or before May 1st.
Signed original on file in Employment Services and Operations.
Issue #1: 06/21/04
Issue #2: 10/28/10
UH System Memorandum 01.A.01
Title 45 Code of Federal Regulations Part 46, Protection of Human Subjects